PhotophobiaNCT06905912
Comparison Between Spectacles and Contact Lenses
A study testing Biomedics55 Premier contact lenses, and Altius Tinted Contact Lenses in people with Photophobia, run by University of Oklahoma at 1 site in United States.
Trial summary
Many people suffer from migraine headaches, some more so than others and a common trigger/complaint is light sensitivity, or photophobia1. Some will go to great lengths to avoid light: a dark room with sunglasses on and blankets over the windows, often missing work/school/social activities, etc. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Photophobia
- What is being tested?
- Biomedics55 Premier contact lenses, and Altius Tinted Contact Lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Two hundred voluntary subjects will be recruited by researching those who have purchased FL-41 tinted spectacles from the Dean McGee Eye Institute Optical Department. If this does not recruit enough subjects then subject referrals will be solicited from the patient population of the Dean McGee Eye Institute and/or neurology clinics throughout the Oklahoma City metro area.
Subjects must meet the following criteria in order to participate in this study:
- Subjects must have worn FL-41 tinted spectacles for at least one month prior to participating in this study.
- Subjects must have at least 20/30 distance visual acuity in each eye while wearing the contact lenses. Altius lenses are currently available in spherical powers from plano to -6.00.
- Subjects must demonstrate the ability to insert and remove contact lenses. Assistance from friends and family is acceptable.
- Subjects must not have an infectious or progressive ocular disease.
Subjects not meeting all of the above criteria will be excluded from participating in this study.
Early Termination:
If a subject feels their photophobia increases to an intolerable level, they can stop wearing that contact lens type and switch to the other the next day or terminate participation in the study. If this occurs, the data from those subjects will still be included in the study data analysis.
If a subject or physician feel that the health of their cornea is at risk, the subject will cease wearing all contact lenses and seek medical care from the Dean McGee Eye Institute.
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Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Dean McGee Eye Institute
Oklahoma City, Oklahoma, 73104
Andrew Melson, MD, 405-271-1091 ext. 11091, Andrew-Melson@dmei.org
About this study
Official title: Comparison Between FL41 Tinted Spectacles, Biomedics55 Premier Contact Lenses, and Altius Tinted Contact Lenses on Photophobia
Many people suffer from migraine headaches, some more so than others and a common trigger/complaint is light sensitivity, or photophobia1. Some will go to great lengths to avoid light: a dark room with sunglasses on and blankets over the windows, often missing work/school/social activities, etc. Several ocular conditions are accompanied by photophobia, ranging from mild to debilitating.
Read the detailed description
Burstein et al. describe a shared neuronal pathway between processing light and migraine signals2. Vessels in the dura mater, which are stimulated during migraines, provide input to the Trigeminal Ganglion (TG), which travels to spinal nuclei, which have connections that synapse in the Lateral Posterior Nucleus (LPN). Some intrinsically photosensitive retinal ganglion cells (ipRGC) also synapse through the LPN. The ipRGC are stimulated by light spectra, such as blue light. The crosstalk between the synapses of the ipRGC and pathways from the dura mater vessels causes an overwhelming number of signals that can cause symptoms ranging from cognitive, visual, motor, olfactory, or auditory disfunctions. Thus, it seems reasonable that a reduction in the amount of light stimulation will help alleviate the overload of signals during a migraine, which will decrease the intensity.
FL-41 glasses filter out approximately 50% of blue light and have been shown effective for migraine reduction3. Altius tinted contact lenses filter out 99% of blue light and therefore should be more effective at reducing photophobia. Since the contact lens has direct contact with and coverage of the cornea, no unfiltered stray light is able to enter the eye thus enhancing its efficacy.
- Conditions
- Photophobia
- Being tested
- Biomedics55 Premier contact lenses, and Altius Tinted Contact Lenses
- Keywords
- Photophobia, Light Sensitivity
- Medical subject headings
- Photophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomedics55 Premier contact lenses, and Altius Tinted Contact LensesDevice
Biomedics55 Premier contact lenses, and Altius Tinted Contact Lenses
| Study group | Role | What they receive |
|---|---|---|
| Altius Tinted Contact Lenses | Experimental | Subjects will be asked to wear either of the two tints available for ten days Receives: Device: Biomedics55 Premier contact lenses, and Altius Tinted Contact Lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing FL-41 Tinted Eyeglasses, Biomedics 55 Premier, and Altius Grey-Green Tinted Contacts
questionnaires - scale of 1 to 10 - no light sensitivity and 10 extreme light sensitivity
Measured: baseline, after 10 days of wearing Biomedics 22 Premier contacts, and after 10 days of wearing Altius colored contacts.
Secondary outcomes (4)
Evaluating FL-41 Tinted Spectacles
questionnaire - scale 1-10 :1-no light sensitivity and 10 extreme light sensitivity
Measured: immediately after subject finished at least 30 days of wearing the spectacles but before wearing the Biomedics 55 Premier Contacts
Evaluating Biomedics 55 Premier Contacts
questionnaire - scale 1-10 :1-no light sensitivity and 10 extreme light sensitivity
Measured: immediately after subject finished 10 days of wearing the Biomedics 55 premier contact lenses but before wearing the Altius tinted Contacts
Evaluating Altius Grey-Green Tinted Contacts
questionnaire - scale 1-10 :1-no light sensitivity and 10 extreme light sensitivity
Measured: immediately after subject finished 10 days of wearing the grey-green tinted contact lenses
Evaluating Altius Amber Tinted Contacts
questionnaire - scale 1-10 :1-no light sensitivity and 10 extreme light sensitivity
Measured: immediately after subject finished 10 days of wearing the amber tinted contacts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PhotophobiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Dean A. McGee Eye Institute
- Responsible party
- Sponsor
- Investigators
- Andrew Melson, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905912
- Sponsor's protocol ID
- 17528
- Status last verified
- Apr 2026
- First submitted
- 21 Aug 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Blackburn MK, Lamb RD, Digre KB, Smith AG, Warner JE, McClane RW, Nandedkar SD, Langeberg WJ, Holubkov R, Katz BJ. FL-41 tint improves blink frequency, light sensitivity, and functional limitations in patients with benign essential blepharospasm. Ophthalmology. 2009 May;116(5):997-1001. doi: 10.1016/j.ophtha.2008.12.031.
PubMed 19410958Burstein R, Noseda R, Fulton AB. Neurobiology of Photophobia. J Neuroophthalmol. 2019 Mar;39(1):94-102. doi: 10.1097/WNO.0000000000000766.
PubMed 30762717Amiri P, Kazeminasab S, Nejadghaderi SA, Mohammadinasab R, Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S. Migraine: A Review on Its History, Global Epidemiology, Risk Factors, and Comorbidities. Front Neurol. 2022 Feb 23;12:800605. doi: 10.3389/fneur.2021.800605. eCollection 2021.
PubMed 35281991
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between FL41 Tinted Spectacles, Biomedics55 Premier Contact Lenses, and Altius Tinted Contact Lenses on Photophobia
- ClinicalTrials.gov ID
- NCT06905912
- Acronym / sponsor ID
- 17528
- Conditions
- Photophobia
- Keywords
- Photophobia, Light Sensitivity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Dean A. McGee Eye Institute
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many people suffer from migraine headaches, some more so than others and a common trigger/complaint is light sensitivity, or photophobia1. Some will go to great lengths to avoid light: a dark room with sunglasses on and blankets over the windows, often missing work/school/social activities, etc. Several ocular conditions are accompanied by photophobia, ranging from mild to debilitating.
Detailed description
Burstein et al. describe a shared neuronal pathway between processing light and migraine signals2. Vessels in the dura mater, which are stimulated during migraines, provide input to the Trigeminal Ganglion (TG), which travels to spinal nuclei, which have connections that synapse in the Lateral Posterior Nucleus (LPN). Some intrinsically photosensitive retinal ganglion cells (ipRGC) also synapse through the LPN. The ipRGC are stimulated by light spectra, such as blue light. The crosstalk between the synapses of the ipRGC and pathways from the dura mater vessels causes an overwhelming number of signals that can cause symptoms ranging from cognitive, visual, motor, olfactory, or auditory disfunctions. Thus, it seems reasonable that a reduction in the amount of light stimulation will help alleviate the overload of signals during a migraine, which will decrease the intensity.
FL-41 glasses filter out approximately 50% of blue light and have been shown effective for migraine reduction3. Altius tinted contact lenses filter out 99% of blue light and therefore should be more effective at reducing photophobia. Since the contact lens has direct contact with and coverage of the cornea, no unfiltered stray light is able to enter the eye thus enhancing its efficacy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Altius Tinted Contact Lenses | Experimental | Device: Biomedics55 Premier contact lenses, and Altius Tinted Contact LensesSubjects will be asked to wear either of the two tints available for ten days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomedics55 Premier contact lenses, and Altius Tinted Contact LensesBiomedics55 Premier contact lenses, and Altius Tinted Contact Lenses | Device | Altius Tinted Contact Lenses |
Primary outcome
Comparing FL-41 Tinted Eyeglasses, Biomedics 55 Premier, and Altius Grey-Green Tinted Contacts
Time frame: baseline, after 10 days of wearing Biomedics 22 Premier contacts, and after 10 days of wearing Altius colored contacts.
questionnaires - scale of 1 to 10 - no light sensitivity and 10 extreme light sensitivity
4 secondary outcomes
Evaluating FL-41 Tinted Spectacles
Time frame: immediately after subject finished at least 30 days of wearing the spectacles but before wearing the Biomedics 55 Premier Contacts
Evaluating Biomedics 55 Premier Contacts
Time frame: immediately after subject finished 10 days of wearing the Biomedics 55 premier contact lenses but before wearing the Altius tinted Contacts
Evaluating Altius Grey-Green Tinted Contacts
Time frame: immediately after subject finished 10 days of wearing the grey-green tinted contact lenses
Evaluating Altius Amber Tinted Contacts
Time frame: immediately after subject finished 10 days of wearing the amber tinted contacts
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Background: PubMed 19410958Blackburn MK, Lamb RD, Digre KB, Smith AG, Warner JE, McClane RW, Nandedkar SD, Langeberg WJ, Holubkov R, Katz BJ. FL-41 tint improves blink frequency, light sensitivity, and functional limitations in patients with benign essential blepharospasm. Ophthalmology. 2009 May;116(5):997-1001. doi: 10.1016/j.ophtha.2008.12.031.
- Background: PubMed 30762717Burstein R, Noseda R, Fulton AB. Neurobiology of Photophobia. J Neuroophthalmol. 2019 Mar;39(1):94-102. doi: 10.1097/WNO.0000000000000766.
- Background: PubMed 35281991Amiri P, Kazeminasab S, Nejadghaderi SA, Mohammadinasab R, Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S. Migraine: A Review on Its History, Global Epidemiology, Risk Factors, and Comorbidities. Front Neurol. 2022 Feb 23;12:800605. doi: 10.3389/fneur.2021.800605. eCollection 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew Melson, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biomedics55 Premier contact lenses, and Altius Tinted Contact Lenses in people with Photophobia, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey S Samples, AS (706-662-7878, scott-samples@dmei.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing FL-41 Tinted Eyeglasses, Biomedics 55 Premier, and Altius Grey-Green Tinted Contacts (time frame: baseline, after 10 days of wearing Biomedics 22 Premier contacts, and after 10 days of wearing Altius colored contacts.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06905912, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.